Tag: Drug Quality Control

IBI Lorenzini will use TraceLink’s serialization solutions

marking
TraceLink, the world’s largest track and trace network, announced that IBI Lorenzini has selected TraceLink’s solutions to ensure compliance with global serialization regulations.

AcelRx Pharmaceuticals obtains EU approval for its analgesic drug

tablets
AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, announced that the European Commission (EC) has approved DZUVEO.

Adents and Microsoft developed a new blockchain serialization solution

blockchain
Adents in collaboration with Microsoft has developed a new unit-level product track & trace platform utilizing Blockchain and AI technologies. Adents NovaTrack offers end-to-end traceability.

Sandoz obtained EC approval for infliximab biosimilar

Sandoz
Sandoz, a Novartis division and the global leader in biosimilars, announced that the European Commission (EC) has approved Zessly (infliximab) for use in Europe.

Bosch Packaging Technology offers new data mining service

blockchain
Bosch Packaging Technology presents data mining service, which has recently been added to the range of pharma services. The aim is to evaluate existing machine data more effectively to identify and eliminate root causes.

Antares Vision presented its new software for pharmaceutical serialization

drug-marking
Antares Vision has introduced ATSFour, an enterprise-level serialization software aimed at fighting counterfeiting in the pharmaceutical industry.

Roszdravnadzor identified 6 falsified drugs and 2 substances in 2017

pills
The measures taken by Roszdravnadzor in 2017 allowed to withdraw 915 batches of medicinal products with substandard quality, which is 0.34% of the total number of batches released into circulation in that year.

Mylan and Biocon obtained marketing authorization from the European Commission

European-Commission
Mylan and Biocon announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission (EC).

EMA verified the withdrawal of Flupirtine analgesic

pills
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human has endorsed EMA’s recommendation to withdraw the marketing authorisation for the pain medicine, because of the risk of serious liver injury.

Russia officially joined the MEDICRIME Convention

medicrime
The Russian Minister of Health deposited the instrument of ratification on the counterfeiting of medical products and crimes involving threats to public health with the Secretary General of the Council of Europe.

Pharmaceutical manufacturers may be fined 5 million rubles for false information

pharma manufacturing
For incomplete or distorted provision of details, which caused harm to the life or health of citizens, the draft law establishes the administrative liability in the form of a fine ranging from one million to five million rubles.

Russian State Duma proposed to toughen punishment for sales of falsified drugs

pills
The members of the Russian State Duma propose to introduce severe penalties, including imprisonment of up to 12 years, for the distribution of falsified medicinal products and medical devices via the Internet.

Russia establishes its National Quality Infrastructure Council

manturov
On March 14, Denis Manturov, the Russian Minister of Industry and Trade, chaired a meeting of the State Commission on Counteraction to Illegal Circulation of Industrial Products.

Few cases of counterfeit drugs to get into circulation via internet in Russia

counterfeit drug
The amount of substandard medicines available on the market has been halved in 2017, while some falsified drugs get into circulation via the Internet, said Mikhail Murashko, the Head of Roszdravnadzor.

US FDA warned OTC drug manufacturers from China and Hong Kong

fda
The US Food and Drug Administration released warning letters sent to two over-the-counter drugmakers in China (Zhejiang Ludao Technology) and Hong Kong Zhejiang (Nan San).

EMA accepted the resubmission for review of Neulasta biosimilar

stada
STADA Arzneimittel AG was informed by Gedeon Richter Plc. that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed biosimilar to Amgen's Neulasta (pegfilgrastim).